The Indian Drug Manufacturers' Association (IDMA) has urged the Director General of Foreign Trade (DGFT) to give complete authority to the Pharmaceutical Export Promotion Council of India (Pharmexcil) for granting exemption to the exporters in the implementation of barcoding, without seeking prior approval of the government as this would only delay the export consignments.
Recently, the association has submitted a representation to Anup Wadhawan, DGFT, department of commerce, ministry of commerce and industry in response to government's notification authorising Pharmexcil as the nodal agency for processing applications of pharma exporters for exemptions from government's barcoding provisions.
The association is of the view that the Pharmexcil is experienced in issuing RCMC judiciously and has been providing excellent support to exporters in their export activities, tracking regulatory requirements of all countries etc for over the past decade.
It has further suggested as the office of DCGI who are already overloaded and understaffed, had expressed their inability to provide data or list of countries seeking exemption, it would have been more prudent to have made the exemption as the rule, and stipulated that specific format and marking on labels of pharma packs needs only be complied with if stipulated by any country for exports.
Earlier, the DGFT had appointed Central Drugs Standard Control Organisation (CDSCO) for the granting the exemption to the exporters on barcoding but the DCGI informed DGFT that the organisation is already burdened with the work load and it would be difficult for the organisation to provide data or list of countries seeking exemption.
Therefore, the DGFT authorised Pharmexcil to grant exemptions to the companies from implementing barcoding in cases where the importing country has its own mandate for barcoding or serialization, with prior approval of the government.